Griessinger Norbert, Sittl Reinhard, Likar Rudolf
Department of Anaesthesiology, Pain Clinic, University of Erlangen-Nuernberg, Erlangen, Germany.
Curr Med Res Opin. 2005 Aug;21(8):1147-56. doi: 10.1185/030079905X53315.
The objective of this post-marketing surveillance study was to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (Transtec*) under routine clinical conditions.
For this open, observational study, patients with moderate to severe cancer or non-cancer pain requiring treatment with an opioid analgesic were recruited at hospitals, outpatient clinics and general practitioners' practices in Germany. Buprenorphine transdermal patches (35 microg/h, 52.5 microg/h or 70 microg/h) were prescribed at physicians' discretion in accordance with the product's Summary of Product Characteristics (SmPC). Patients assessed their pain relief as 'very good', 'good', 'satisfactory', 'poor' or 'no effect'. Investigators were instructed to report all adverse events throughout the observation period. On completion, effectiveness and tolerability were evaluated for the overall study population, cancer and non-cancer patients, and patients < 70 years and > or = 70 years. Other analyses assessed pain relief with respect to previous opioid treatment and increased patch strength, and in patients who remained on their original dose. The total observation time was 9 months, and the average individual documented treatment time was 60.8 days.
A total of 13,179 patients were evaluated; 3690 (28%) with cancer pain and 9489 (72%) with non-cancer pain. The most frequent diagnoses in non-cancer patients were musculoskeletal disorders (77%) and neuropathy (23%). In the great majority of cases (78%), treatment was started with the 35 microg/h patch. The initial dose needed to be increased subsequently only in about 18% of subjects. Buprenorphine transdermal patches provided effective, sustained and dose-dependent analgesia in patients with cancer and non-cancer pain, irrespective of the patients' age or pain syndromes. Whereas good or very good pain relief was documented only for 6% of the patients with the initial assessment, this percentage increased to 71% at the first follow-up and 80% at the final assessment. Fewer than 5% of subjects discontinued treatment owing to unsatisfactory pain relief. Altogether, adverse events were documented for 2874 patients (22%), whereas a relationship with trans dermal buprenorphine (adverse drug reactions) was assumed for only 10% (2220 adverse drug reactions in 1330 patients). The tolerability profile was as expected for an opioid and did not vary to a relevant extent with either the patient's age or the cause of pain (cancer or non-cancer). No evidence emerged of any previously unknown side effects.
Buprenorphine transdermal patches are well tolerated and effective in the treatment of chronic cancer and non-cancer pain, irrespective of the patients' age. There was no clinically relevant development of tolerance.
本上市后监测研究的目的是收集丁丙诺啡透皮贴剂（Transtec*）在常规临床条件下标记用途的有效性和安全性数据。
对于这项开放性观察性研究，在德国的医院、门诊诊所和全科医生诊所招募了需要使用阿片类镇痛药治疗的中度至重度癌症或非癌症疼痛患者。丁丙诺啡透皮贴剂（35微克/小时、52.5微克/小时或70微克/小时）由医生根据产品特性摘要（SmPC）自行决定处方。患者将其疼痛缓解程度评估为“非常好”“好”“满意”“差”或“无效果”。研究人员被要求报告整个观察期内的所有不良事件。研究结束时，对整个研究人群、癌症和非癌症患者以及年龄<70岁和≥70岁的患者进行有效性和耐受性评估。其他分析评估了与先前阿片类药物治疗和增加贴剂强度相关的疼痛缓解情况，以及维持原剂量患者的疼痛缓解情况。总观察时间为9个月，平均个体记录治疗时间为60.8天。
共评估了13179例患者；其中3690例（28%）为癌症疼痛患者，9489例（72%）为非癌症疼痛患者。非癌症患者中最常见的诊断是肌肉骨骼疾病（77%）和神经病变（23%）。在绝大多数情况下（78%），治疗从35微克/小时的贴剂开始。仅约18%的受试者随后需要增加初始剂量。丁丙诺啡透皮贴剂在癌症和非癌症疼痛患者中提供了有效、持续且剂量依赖性的镇痛效果，与患者年龄或疼痛综合征无关。初始评估时仅有6%的患者记录为疼痛缓解良好或非常好，而在首次随访时这一比例增至71%，在最终评估时为80%。因疼痛缓解不令人满意而停药的受试者不到5%。总共2874例患者（22%）记录了不良事件，而仅10%（1330例患者中的2220例药物不良反应）被认为与丁丙诺啡透皮贴剂有关（药物不良反应）。耐受性特征与阿片类药物预期一致，在患者年龄或疼痛原因（癌症或非癌症）方面没有显著差异。没有出现任何先前未知的副作用的证据。
丁丙诺啡透皮贴剂耐受性良好，对慢性癌症和非癌症疼痛有效，与患者年龄无关。没有出现临床上相关的耐受性发展。
